Picap is completely absorbed after oral administration. It
undergoes entherohepatic cyclling and is bound to plasma porteins.

[Therapeutic indications]

Piroxicam is a non-steroidal anti-inflammatory agent with analgesic
and antipyretic activity.Piroxicam is indicated for the symptomatic relief of rheumatoid
arthritis, osteoarthritis or ankylosing spondylitis.

Special Precaution :Sever impairment of hepatic or renal
function,hypertension,surgery,hemorrhagic disorders,Prolonged
use,Pregnancy and Post-Pregnancy

[Posology and method of administration]

Posology

The prescription of piroxicam should be initiated by physicians
with experience in the diagnostic evaluation and treatment of
patients with inflammatory or degenerative rheumatic diseases.

The maximum recommended daily dose is 20mg.

Undesirable effects may be minimised by using the minimum effective
dose for the shortest duration necessary to control symptoms. The
benefit and tolerability of treatment should be reviewed within 14
days. If continued treatment is considered necessary, this should
be accompanied by frequent review.

Given that piroxicam has been shown to be associated with an
increased risk of gastrointestinal complications, the possible need
for combination therapy with gastroprotective agents (e.g.
misoprostol or proton pump inhibitors) should be carefully
considered, in particular for elderly patients.

Adults:

Initially 20mg given as a single daily dose. The majority of
patients may be maintained on 20mg a day, a relatively small group
of patients may be maintained on 10mg daily.

Children:

Not recommended for children under 12 years of age.

Elderly:

There are no specific modifications required in the elderly, except
where hepatic, renal or cardiac function is impaired, in which case
dosage should be individually assessed.

The elderly are at increased risk of the serious consequences of
adverse reactions. If an NSAID is considered necessary, the lowest
effective dose should be used and for the shortest possible
duration. The patient should be monitored regularly for GI bleeding
during NSAID therapy.

[Method of Administration]

For oral administration. To be taken preferably with or after food.

[Contraindications]

• Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1, previous skin reaction
(regardless of severity) to piroxicam, other NSAIDs and other
medications.

• Patient history of gastrointestinal disorders that predispose to
bleeding disorders such as ulcerative colitis, Crohn's disease,
gastrointestinal cancers or diverticulitis.

• Concomitant use with other NSAIDs, including COX-2 selective
NSAIDs and aspirin at analgesic doses.

• Concomitant use with anticoagulants.

• Piroxicam should not therefore be administered to patients in
whom aspirin and other NSAIDs induce the symptoms of angioneurotic
oedema, asthma, rhinitis, nasal polyps or urticaria.

• Patients with severe heart failure.

[Special warnings and precautions for use]

Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control symptoms (see
section 4.2, and GI cardiovascular risks below). The clinical
benefit and tolerability should be re-evaluated periodically and
treatment should be immediately discontinued at the first
appearance of cutaneous reactions or relevant gastrointestinal
events.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a
history of hypertension and/or mild to moderate congestive heart
failure as fluid retention and oedema have been reported in
association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of some
NSAIDs (particularly at high doses and in long term treatment) may
be associated with a small increased risk of arterial thrombotic
events (for example myocardial infarction or stroke). There are
insufficient data to exclude such a risk for piroxicam.

Patients with uncontrolled hypertension, congestive heart failure,
established ischaemic heart disease, peripheral arterial disease,
and/or cerebrovascular disease should only be treated with
piroxicam after careful consideration. Similar consideration should
be made before initiating longer-term treatment of patients with
risk factors for cardiovascular disease (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, smoking).

Cardiovascular, Renal and Hepatic Impairment

The administration of an NSAID may cause a dose dependent reduction
in prostaglandin formation and precipitate renal failure. Patients
at greatest risk of this reaction are those with impaired renal
function, cardiac impairment, liver dysfunction, those taking
diuretics and the elderly. Renal function should be monitored in
these patients

In rare cases, NSAIDs may cause interstitial nephritis,
glomerulonephritis, papillary necrosis and the nephrotic syndrome.
Due to the renal excretion of piroxicam, patients with severely
impaired renal function should be closely monitored.

Elderly

The elderly have an increased frequency of adverse reactions to
NSAIDs, especially gastrointestinal bleeding and perforation which
may be fatal

Respiratory disorders

Caution is required if administered to patients suffering from or
with a previous history of bronchial asthma since NSAIDs have been
reported to precipitate bronchospasm in such patients.

Due to reports of adverse eye findings with NSAIDs, it is
recommended that patients who develop visual complaints during
treatment with piroxicam have ophthalmic evaluation.

Gastrointestinal bleeding, ulceration and perforation

NSAIDs, including piroxicam, can cause serious gastrointestinal
events including bleeding, ulceration, and perforation of the
stomach, small intestine or large intestine, which can be fataL.
These serious adverse events can occur at any time, with or without
warning symptoms, in patients treated with NSAIDs.

NSAID exposures of both short and long duration have an increased
risk of serious GI event. Evidence from observational studies
suggests that piroxicam may be associated with a high risk of
serious gastrointestinal toxicity, relative to other NSAIDs.

Patients with significant risk factors for serious GI events should
be treated with piroxicam only after careful consideration

The possible need for combination therapy with gastro-protective
agents (e.g. misoprostol or proton pump inhibitors) should be
carefully considered and also for patients requiring concomitant
low dose aspirin, or other drugs likely to increase
gastrointestinal risk

Serious GI Complications

Identification of at-risk subjects: The risk for developing serious
GI complications increases with age. Age over 70 years is
associated with high risk of complications. The administration to
patients older than 80 years should be avoided.

The risk of GI bleeding, ulceration or perforation is higher with
increasing NSAID doses, in patients with a history of ulcer,
particularly if complicated with haemorrhage or perforation, and in
the elderly. These patients should commence treatment on the lowest
dose available.

When GI bleeding or ulceration occurs in patients receiving
piroxicam the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of
gastrointestinal disease (ulcerative colitis, Crohn's disease) as
these conditions may be exacerbated.

Patients taking concomitant oral corticosteroids, selective
serotonin reuptake inhibitors (SSRls) or anti-platelet agents such
as low-dose aspirin are at increased risk of serious GI
complications . As with other NSAIDs, the use of piroxicam in
combination with protective agents (e.g. misoprostil and proton
pump inhibitors) must be considered for these at-risk patients.

Patients and physicians should remain alerted for signs and
symptoms of GI ulceration and/or bleeding during piroxicam
treatment. Patients should be asked to report any new or unusual
abdominal symptom during treatment. If a gastrointestinal
complication is suspected during treatment, piroxicam should be
discontinued immediately and additional clinical evaluation and
treatment should be considered.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed
connective tissue disorders there may be an increased risk of
aseptic meningitis

Dermatological

Serious skin reactions, some of them fatal, including exfoliative
dermatitis, Stevens-Johnson syndrome, and toxic epidermal
necrolysis, have been reported very rarely in association with the
use of NSAIDs (see section 4.8). Evidence from observational
studies suggests that piroxicam may be associated with a higher
risk of serious skin reactions than other NSAIDs.

Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS)
and toxic epidermal necrolysis (TEN) have been reported with the
use of piroxicam. Patients should be advised of the signs and
symptoms and monitored closely for skin reactions. The highest risk
for occurrence of SJS or TEN is within the first weeks of
treatment. If symptoms or signs of SJS or TEN (e.g. progressive
skin rash often with blisters or mucosal lesions) are present,
piroxicam treatment should be discontinued. The best results in
managing SJS and TEN come from early diagnosis and immediate
discontinuation of any suspect drug. Early withdrawal is associated
with a better prognosis. If the patient has developed SJS or TEN
with the use of piroxicam, piroxicam must not be re-started in this
patient at any time.

Patients appear to be at a highest risk of these reactions early in
the course of therapy, the onset of the reaction occurring in the
majority of cases within the first month of treatment. Piroxicam
should be discontinued at the first appearance of skin rash,
mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertilty

The use of piroxicam may impair female fertility and is not
recommended in women attempting to conceive. In women who have
difficulties conceiving or who are undergoing investigation of
infertility, withdrawal of Piroxicam should be considered.

Headache

Where analgesics are used long-term (>3 months) with
administration every two days or more frequently, headache may
develop or worsen. Headache induced by overuse of analgesics (MOH
medication-overuse headache) should not be treated by dose
increase. In such cases, the use of analgesics should be
discontinued in consultation with the doctor.

Lactose

Piroxicam contain lactose. Patients with rare hereditary problems
of galactose intolerance, the lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicinal
product.

Dosage Adults :20mg daily as a single dose. Musculo-skeketal
disorders: Initially 40mg daily for 2 days then 20mg daily for 7-14
days. Gout. Intially 40mg as s Single Dose then 40mg daily in a
single or divided doses for next 4-6 days.Post-operative &
post-traumatic pain:40mg daily as a single or divided doses for
first two days.